There
are five USP general chapters that link with USP's taxonomy for pharmaceutical
dosage forms: Injections and Implanted Drug Products 〈1〉,
Oral Drug Products—Product Quality Tests 〈2〉,
Topical and Transdermal Drug Products—Product Quality Tests 〈3〉,
Mucosal Drug Products—Product Quality Tests 〈4〉,
and Inhalation and Nasal Drug Products—General Information and Product Quality
Tests 〈5〉. The five
general chapters provide critical product quality attributes for the various
dosage forms by the various routes of administration.

Chapter 1029 Good Documentation
Guidelines

(Revision
proposal target, USP39-NF34 2nd Supplement)

This
proposed new general chapter provides guidelines on how to develop and maintain
good documentation practices within Good Manufacturing Practice (GMP)
operations.

Chapter 1228.3 Depyrogenation by
Filtration

(Revision
proposal target, USP39-NF34 2nd Supplement)

This
is an additional general chapter to the Depyrogenation 〈1228〉
family of chapters. This chapter provides an overview of depyrogenation by
filtration and the various approaches and technologies used to complete it

Chapter 1228.5 Endotoxin Indicators for
Depyrogenation [NEW]

(Revision
proposal target, USP39-NF34 2nd Supplement)

This
is an additional general chapter to the Depyrogenation 〈1228〉
family of chapters. In this chapter the biological tool used to challenge the
depyrogenating capabilities of a process will be defined as an endotoxin
indicator. The following topics will be discussed in this chapter: endotoxin
and lipopolysaccharide, applications of endotoxin indicators, preparation and
use of endotoxin indicators, and analysis of test results.

Chapter 1229.13 Sterilization-in-place
[NEW]

(Revision
proposal target, USP39-NF34 2nd Supplement)

A
new general chapter as an addition to the Sterilization of Compendial Articles 〈1229〉
family of chapters. This chapter discusses sterilization of a system or piece
of process equipment in situ (sterilization-in-place; SIP) to reduce the need
for post-sterilization handling. This chapter provides information on the
common elements of the SIP process, different physical methods used for
performing SIP, and routine process control

Chapter 1231 Water for Pharmaceutical
Purposes

(Revision
proposal target, USP39-NF34 2nd Supplement)

The
following list includes a summary of the changes:

Updating
the chapter to improve the organization and clarity of the information and
remove redundant discussion text. This includes the organization into nine
specific sections listed below.

Significant
revisions have been made or discussion added in several reorganized sections:
1. Introduction; 2. Source Water Considerations; 3. Waters Used for
Pharmaceutical Manufacturing and Testing Purposes; 4. Validation and
Qualification of Water Purification, Storage, and Distribution Systems; 5.
Design and Operation of Purified Water and Water for Injection Systems; 6.
Sampling; 8. Microbial Considerations; and 9. Alert and Action Levels and
Specifications. The remaining section 7. Chemical Evaluations is not being
revised at this time.